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ClinicalTrials.gov Identifier: NCT01547689

Recruitment Status : Unknown

Verified February 2016 by Affiliated Hospital to Academy of Military Medical Sciences. Recruitment status was: Active, not recruiting

The primary purpose of this study is to evaluate the safety and the tolerability of UC-MSC (Human Umbilical Cord-Derived Mesenchymal Stem Cell) .This study is also to investigate the efficacy of this treatment in patients with Alzheimer's disease (AD).

Condition or disease

Intervention/treatment

Phase

Alzheimer's Disease

Biological: Human Umbilical Cord Derived MSC

Phase 1Phase 2

Detailed Description:

To date, most AD patients who seek treatment already have neuritic plaques, neurofibrillary tangles, and neurodegeneration. At this stage of the disease, perhaps a multi-faceted approach to halt the toxicity of amyloid-β peptides and promote cell survival and/or replace lost cells would be most beneficial.Most of the treatments for Alzheimer disease are chemical drug which can improve the symptoms but is not able to inhibit the disease progression.

Mesenchymal stem cells (MSCs) are multipotent cells that are being clinically explored as a new therapeutic for treating a variety of immune-mediated diseases.Preclinical studies of the mechanism of action suggest that the therapeutic effects afforded by MSC transplantation are short-lived and related to dynamic, paracrine interactions between MSCs and host cells.Clinical trials of MSCs thus far have shown no adverse reactions to allogeneic versus autologous MSC transplants. Clinical studies showed that umbilical cord derived MSC is immunologically stable and not toxic.

This study is to evaluate the safety and the tolerability of UC-MSC (Human Umbilical Cord-Derived Mesenchymal Stem Cell).This study is also to investigate the efficacy of this treatment in patients with Alzheimer's disease.

Number of participants with adverse event [ Time Frame: 10 weeks from post-administration ]

All subjects: Follow-up a year Number of participants with adverse event, number of participants with normal range of vital signs and laboratory examination Indexes of safety evaluation: symptom or sign, laboratory examination, adverse reaction rate

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Subject with vascular dementia as determined by the clinical criteria of Design Standards Manual(DSM) IV and the imaging criteria of Erkinjuntii

Subject with severe white matter hyperintensities (WMH); Severe WMH is defined that length of the deep white matter is 25 mm or longer and length of the periventricular capping/banding is 10 mm or longer.